Grassley briefs Dems on outstanding FDA issues

Outgoing Senate Finance Committee chairman Chuck Grassley (R-IA) has written Democrat Senate HELP Committee leaders with a laundry list of FDA shortcomings that he hopes they will address in the new session beginning in January. In a letter, he summarized “systemic” FDA problems, such as drug safety, scientific morale, and a “too cozy” relationship with the industries it regulates.

Grassley complained about FDA senior officials who “disregarded and downplayed important concerns and warnings from its own scientists,” and their pressures to have scientists change their findings or conclusions regarding a safety or efficacy issue.

The day after Grassley sent his letter, incoming HELP Committee chairman Edward M. Kennedy (D-MA) took the opportunity of the committee's last, lame-duck session to lambaste their impact on the FDA.

“Science has, too often, had to take a backseat at the very agency which should be setting the standard for objectivity and integrity,” he said.